Study of Cetuximab in Combination With Tarceva in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207077
First received: September 12, 2005
Last updated: April 7, 2011
Last verified: July 2008
  Purpose

The purpose of this study is to find a safe and effective dose of the combination of cetuximab (Erbitux) and Tarceva (erlotinib).


Condition Intervention Phase
Neoplasms
Drug: Cetuximab + Erlotinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Cetuximab in Combination With Erlotinib in Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety and efficacy of the combination of Tarceva and Erbitux

Secondary Outcome Measures:
  • Radiographic response

Estimated Enrollment: 33
Study Start Date: August 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Cetuximab + Erlotinib
IV solution + tablet, IV+ oral, ERB 100 mg/m2, 200 mg/m2, 250 mg/m2 IV + Erl 150 mg tablet, ERB weekly/ Erl once daily, Until disease progression.
Other Name: Erbitux

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Measurable disease
  • Life expectancy of at least 3 months
  • Must have at least one prior chemotherapy containing a platinum

Exclusion Criteria:

  • Known or documented brain metastases
  • Prior cetuximab therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207077

Locations
United States, Delaware
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00207077     History of Changes
Other Study ID Numbers: CA225-101
Study First Received: September 12, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Advanced Solid Tumors

Additional relevant MeSH terms:
Neoplasms
Cetuximab
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014